Delhi High Court seeks Central government response on PIL seeking examination of clinical data before granting approval to stents

The Delhi High Court on Tuesday issued notice to the Centre government, Department of Pharmaceuticals and National Pharmaceuticals Pricing Authority (NPPA) on a plea demanding a mechanism to examine the clinical studies and data before before a cardiac or coronary stent is granted approval for use in India. .A division bench of Chief Justice Satish Chandra Sharma and Justice Subramonium Prasad sought response from the government authorities and listed the case for further consideration on May 10, 2023. .The court was dealing with a Public Interest Litigation (PIL) petition filed by advocate Mayank Kshirsagar.Additional Solicitor General (ASG) Chetan Sharma appeared for the Union government in the matter and stated that the issue raised in the petition is very important and the government will file its response on the matter.“This is a cause of concern… This has a very wide impact and he (petitioner) is raising some substantial question. This needs to be sorted out," the ASG said.The case will now be heard on May 10, 2023..The plea, filed through advocate Tushar Singh and argued by advocate Jawahar Lal, stated that at present, cardiac or coronary stents are allowed to be manufactured/imported and sold without or with negligible supporting clinical study and data. This is done merely based on predicate (device/literature), submitted by the manufacturer/importer, the plea said. It, therefore, said that the government ought to develop a robust mechanism for approval of devices like stents similar to the United States' Food & Drugs Administration (FDA). "For approval of a medical device including Stents for sale, FDA requires a critical, large and randomized study, which are monitored during the span of several years (in general more than one year) and the medical device is required to demonstrate delivery of stated benefits without any side effects and not merely ensuring that the patient survives post-surgery," the plea said. .Kshirsagar also demanded that the government should consider whether the Drug Eluting Stents (DES) should be classified into two categories and then fix the ceiling price accordingly. "[First] basic DES which addresses common indications (conditions/ diseases) like symptomatic ischemic disease, de-novo blockages and [Second] advanced DES which addresses specialized indications/conditions/diseases such as diabetes, higher bleed risk, calcified blockage, long blockage, left main disease, multiple blockages amongst others, and accordingly fix the Ceiling Price.".The plea further said that though the petitioner is not challenging the government's decision to fix the ceiling price of stents, bundling a wide range of DES in a single category and fixing single uniform ceiling price has resulted in withdrawal of advanced DES brands from India. "Because of the common Ceiling Price fixed for all DES by the Respondent No.3 (NPPA), technological advanced DES that are available elsewhere in the world have not been made available/introduced in India, thereby denying advanced & technologically improved DES being available to patients in India," it was submitted.